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Trial record 1 of 2 for:    Boehringer Impulsivity
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Fingerprinting of Impulsivity

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02722174
First received: March 23, 2016
Last updated: June 14, 2017
Last verified: June 2017
  Purpose
The study aims to examine a battery of behavioral and questionnaire measures in 4 disorders clinically associated with impulsivity and in health controls, to: 1) investigate if the different populations have a distinct behavioral profile, and 2) to investigate if there are specific measures that are reliable and sensitive measures of impulsivity across diagnoses.

Condition
Impulse Control Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fingerprinting of Impulsivity in Four Diagnostic and Statistical Manual of Mental Disorders, Version 5 (DSM-5) Psychiatric Disorders That Have Been Clinically Associated With Impulsivity Using a Battery of Questionnaires and Behavioral Laboratory Tests

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Go/No Go Task [ Time Frame: up to 5 weeks ]
  • Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Stop Signal Reaction Time (SSRT) Task [ Time Frame: up to 5 weeks ]
  • Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Computerized Monetary Choice Task [ Time Frame: up to 5 weeks ]
  • Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Barratt Impulsiveness Questionnaire version 11 (BIS-11) [ Time Frame: up to 5 weeks ]
  • Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Immediate Memory Task (IMT) [ Time Frame: up to 5 weeks ]
  • Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Urgency, Premeditation, Perseverance, Sensation Seeking and Positive Urgency (UPPs-P) Impulsive Behavior Scale [ Time Frame: up to 5 weeks ]

Secondary Outcome Measures:
  • Antisaccade performance measured as change from baseline to follow-up visit at 4 (+/-1) weeks on the eye tracker [ Time Frame: up to 5 weeks ]

Estimated Enrollment: 240
Actual Study Start Date: July 22, 2016
Estimated Study Completion Date: July 13, 2018
Estimated Primary Completion Date: July 13, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
BED
Binge Eating Disorder
ADHD
Attention Deficit Hyperactivity Disorder
SUD, cocaine subtype
Stimulant Use Disorder, cocaine subtype
BPD
Borderline Personality Disorder
BPD, Cohort 2
Borderline Personality Disorder, Cohort 2
HC
Healthy Controls

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
subjects meeting criteria for one of the described cohorts
Criteria

Inclusion criteria:

All cohorts:

- Males and females ages 18-50.

Healthy Control cohort:

- Volunteers in generally good Psychiatric and non-Psychiatric medical health

Borderline Personality Disorder (2 cohorts):

- Subjects who meet Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) criteria for Borderline Personality Disorder

Binge Eating Disorder cohort:

- Subjects who meet DSM-V criteria for Binge Eating Disorder.

Stimulant Use Disorder cohort:

- Subjects who meet DSM-V criteria for current Stimulant Use Disorder, subtype cocaine, moderate or severe use

Attention Deficit Hyperactivity Disorder cohort:

- Subjects who meet DSM-V criteria for adult Attention Deficit Hyperactivity Disorder

Exclusion criteria:

General:

  • Positive breathalyzer test for alcohol at any study visit
  • History of clinically significant neurologic disorders or head trauma with loss of consciousness greater than 30 minutes
  • Clinically significant non-psychiatric medical disorder requiring ongoing treatment as judged by the investigator.
  • Unwillingness or inability to sign a written informed consent form
  • Pregnancy as assessed by a urine test for ß-Human Chorionic Gonadotropin (ß-HCG) at screening visit
  • Medical or physical contraindications for participation (see below), based on medical history interview, as judged by the investigator
  • Unwilling to refrain from tobacco use one hour prior to testing until after conclusion of testing

Healthy Controls:

  • Current or past DSM-V Axis II diagnoses of Cluster B Personality disorders
  • Current or past DSM-V Axis I diagnoses based on the Structured Clinical Interview for DSM-V (SCID) (including the eating disorders and ADHD module)
  • History of arrest or incarceration
  • Positive urine drug screen for cannabis, cocaine, opiates, amphetamine, and benzodiazepines at any visit
  • Current Tobacco Users

Borderline Personality Disorder Subjects:

  • Current or past DSM-V Axis I diagnoses other than Tobacco Use disorder or Past Major Depressive Disorder
  • Current or past DSM-V Axis II diagnoses other than Cluster B personality disorders
  • Positive urine drug screen for cannabis, cocaine, opiates, amphetamine, and benzodiazepines at any visit
  • Antipsychotic medication or mood stabilizers taken within the last 30 days or change in antidepressant medication within the last 30 days.

Binge Eating Disorder Subjects:

  • Current or past DSM-V Axis I diagnoses other than binge eating disorder (current bulimia also excluded) and Tobacco Use Disorder.
  • Current or past DSM-V Axis II diagnoses of Cluster B Personality disorders
  • Positive urine drug screen for cannabis, cocaine, opiates, amphetamine, and benzodiazepines at any visit

Stimulant Use Disorder, Cocaine Subtype Subjects:

  • Current or past DSM-V Axis I diagnoses other than Stimulant Use Disorder, minor Cannabis Use Disorder, minor alcohol use disorder and Tobacco Use Disorder , or Past Substance Induced Mood Disorder
  • Current or past DSM-V Axis II diagnoses of Cluster B Personality disorders
  • Positive urine drug screen for opiates, amphetamine, and benzodiazepines at any visit

ADHD Subjects:

  • Current or past DSM-V Axis I diagnoses other than ADHD
  • Current or past DSM-V Axis II diagnoses of Cluster B Personality disorders
  • Stimulant medication taken the morning of behavioral testing.
  • Positive urine drug screen for cannabis, cocaine, opiates, amphetamine, methamphetamine or benzodiazepines at any visit. Subjects with a valid prescription for amphetamines for the treatment of ADHD will not be excluded.
  • Unwilling or unable to withhold medications prescribed for treatment of ADHD on the morning of any clinic visit.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02722174

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23219
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02722174     History of Changes
Other Study ID Numbers: 352.2073
Study First Received: March 23, 2016
Last Updated: June 14, 2017

Additional relevant MeSH terms:
Impulsive Behavior
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 23, 2017